0

COVID-19 Vaccination Plan STATE OF MISSOURI

Interagency COVID-19 Vaccination Planning Team November 11, 2020

Table of Contents

Record of Changes ........................................................................................................................................ 4

Introduction .................................................................................................................................................. 5

Executive Summary ....................................................................................................................................... 6

Section 1: COVID-9 Vaccination Preparedness Planning .............................................................................. 7

Program Planning Activities ...................................................................................................................... 7

Continuous Quality Improvement Efforts ................................................................................................. 7

Section 2: COVID-19 Organizational Structure and Partner Involvement .................................................... 9

Organizational Structure and Teammates- From Planning to Implementation ....................................... 9

Recruiting /Engaging Diverse Partners ................................................................................................... 10

Section 3: Phased Approach to COVID-19 Vaccination ............................................................................... 12

Section 4: Critical Populations .................................................................................................................... 15

Identification & Quantification of Critical Populations ........................................................................... 15

Subset Sequencing Strategy .................................................................................................................... 17

Engaging Critical Populations .................................................................................................................. 20

For additional Information: Appendices include Population Targeting Maps ........................................ 20

Section 5: COVID-19 Provider Recruitment and Enrollment ...................................................................... 21

Provider Validation ................................................................................................................................. 22

Initial Vaccine Providers/Location for Critical Populations ..................................................................... 22

Provider Training ..................................................................................................................................... 22

Vaccine Redistribution Strategy/ Principles ............................................................................................ 22

Equitable Access to Vaccines .................................................................................................................. 23

Community-based (non-chain) Pharmacies ............................................................................................ 23

Section 6: COVID-19 Vaccine Administration Capacity ............................................................................... 24

Theoretical Approaches to Vaccination Capacity ................................................................................... 24

Practical Application to Vaccine Availability Scenarios ........................................................................... 24

Impact of Vaccination Capacity Modeling on Provider Recruitment ...................................................... 25

For additional Information: Appendices include Satellite and Curbside Vaccination Site Info ............... 25

Section 7: COVID-19 Vaccine Allocation, Ordering, Distribution, and Inventory Management ................. 26

Vaccine Allocation Strategy .................................................................................................................... 26

Cold-chain Storage Assessment/ Planning Impacts ................................................................................ 26

Vaccination Ordering Process ................................................................................................................. 26

Unplanned Vaccine Redistribution ......................................................................................................... 26

Vaccine Wastage Monitoring .................................................................................................................. 27

Section 8: COVID-19 Vaccine Storage and Handling ................................................................................... 28

Site-specific Issues................................................................................................................................... 28

Individual Provider Location ............................................................................................................... 28

Satellite, temporary, or off-site settings ............................................................................................. 28

Planned redistribution from depots to individual locations and from larger to smaller locations ..... 28

Unplanned repositioning among provider locations .......................................................................... 28

Assessment of Provider/Depot Storage and Temperature Monitoring ................................................. 28

For additional Information: Appendices include Refrigerated / Frozen Vaccine Storage/Monitoring Info ................................................................................................................................................................ 28

Section 9: COVID-19 Vaccine Administration Documentation and Reporting............................................ 29

Existing Infrastructure ............................................................................................................................. 29

Provider Readiness / Documentation ..................................................................................................... 29

Vaccination Delivery Monitoring ............................................................................................................ 29

Section 10: COVID-19 Vaccination Second-Dose Reminders ...................................................................... 30

Section 11: COVID-19 Requirements for IISs or Other External Systems ................................................... 31

WebIZ/DUA ............................................................................................................................................. 31

Data Exchange/Interface/Quality Monitoring ........................................................................................ 31

Provider Enrollment Strategy .................................................................................................................. 31

Data Collection ........................................................................................................................................ 31

High Volume/Contingency Documentation ............................................................................................ 32

Section 12: COVID-19 Vaccination Program Communication ..................................................................... 33

Comprehensive, Coordinated Campaign ................................................................................................ 33

Emergency/Crisis Communication, Timely Updates ............................................................................... 34

For additional Information: Appendices include a Marketing/Communications Activity Plan ............... 35

Section 13: Regulatory Considerations for COVID-19 Vaccination ............................................................. 36

EUA/VIS Availability ................................................................................................................................ 36

EUA/VIS Delivery ..................................................................................................................................... 36

For additional Information: Appendices include a Legal/Regulatory FAQ .............................................. 36

Section 14: COVID-19 Vaccine Safety Monitoring ...................................................................................... 37

Section 15: COVID-19 Vaccination Program Monitoring ............................................................................ 38

Provider enrollment ................................................................................................................................ 38

Vaccination Delivery Demographics ....................................................................................................... 38

IIS or other designated system performance ......................................................................................... 38

Provider-level data reporting/Dose Coverage ........................................................................................ 38

Vaccine ordering and distribution........................................................................................................... 38

Budgeting/Materiel Management .......................................................................................................... 39

Communications/Messaging .................................................................................................................. 39

References .................................................................................................................................................. 40

Record of Changes

Date of the original version: October 1, 2020

Date Reviewed

Change Number

Date of Change

Description of Change

10/01/2020 1 10/6/2020 Revision of Executive Summary/Intro 10/09/2020 2 10/9/2020 Revisions to entire plan based on

stakeholder feedback 10/11/2020 3 10/11/2020 Revisions to entire plan based on

editors feedback 10/14/2020 4 10/14/2020 Copy editing of the plan (minus

appendices) 10/15/2020 5 10/15/2020 Final edits of the plan (minus

appendices) 10/15/2020 6 10/15/2020 Final edits of the entire plan

11/10/2020 7 11/11/2020 CDC revisions incorporated 12/16/2020 8 12/16/2020 Provider readiness section revised

Introduction

We are in an unprecedented season during this COVID-19 pandemic. While it's been challenging to tackle these unforeseen circumstances, it's also showed us that our best solutions come by working collaboratively and collectively to serve our citizens. We are better together. We continue to be resilient, resourceful, and re-energized as we proactively work on this next critical phase of our pandemic plan—COVID-19 vaccinations.

Missouri has established the Missouri Interagency COVID-19 Vaccination Planning Team to find a "Show Me Strong" solution to designing and implementing a statewide COVID-19 vaccination plan. While this next phase has some challenges to overcome, including frequently changing national guidance, timeline uncertainties, and unprecedented scope of work, we have worked to build a team of solution starters to overcome the hurdles we see ahead. The Missouri Department of Health and Senior Services' Bureau of Immunizations convened a broad group of state and local government, healthcare and social work professionals, industry partners, community advocacy groups, and military logisticians to start this process. This plan represents a combination of innovation and preparation. It also builds upon successful emergency-management strategies refined over years of use and exercise while using the strength of Missouri's citizens and communities to respond locally to help their neighbors and communities.

With the strong likelihood of limited vaccine availability in the initial phase of this COVID-19 vaccination effort, this plan initially focuses those limited doses toward reducing or stopping death and disability by lessening the stress on our healthcare system caring for our impacted citizens. This is a vital first step to protecting those delivering critical care to protect our most vulnerable. As vaccine availability expands, we will strategically target vaccination efforts to those residents most at risk—our elderly and those with medical conditions, placing them at high risk for poor outcomes. Simultaneously, we will also begin efforts to accelerate Missouri's economic recovery by protecting our schools and critical businesses. As vaccine availability continues to increase, the plan ensures every Missourian who wants a vaccination, regardless of who they are or where they live, will be able to obtain one at no cost.

The unique aspect of the Missouri COVID-19 Vaccination Plan is the primary and essential role of our local communities, including the collaboration with the State to assist and be a vital resource for their efforts. While a State Implementation Team (SIT) is responsible for coordinating with federal agencies, our plan empowers local Regional Implementation Teams (RIT) with additional financial and technical support from the State to convene local community leaders, citizen advocates, and local healthcare providers. Our plan builds on the existing network of immunizing providers across Missouri, including augmenting their efforts in areas of provider shortages to ensure a safe and effective vaccine is distributed equitably and efficiently in Missouri.

Executive Summary

The Centers for Disease Control and Prevention (CDC) and federal Operation Warp Speed have established a framework for effective State planning to distribute the forthcoming COVID-19 vaccination. This Missouri COVID-19 Vaccination Implementation Plan represents the culmination of planning by a cross-sectional coalition of stakeholders, the Missouri Department of Health and Senior Services, and the Missouri National Guard to successfully provide the CDC with a state framework vaccinating willing residents to ensure safe and healthy Missourians. This is a guiding document outlining the overall strategy and will be followed closely with additional plans, tactics, and measurements for successful implementation.

The plan's specific objectives include:

1. Identifying key stakeholders and partnerships necessary for effective implementation. 2. Identifying necessary infrastructure and resources and preparing for deployment. 3. Setting the stage for gap analysis and the developing countermeasures necessary for success. 4. Establishing systems for ensuring ongoing planning.

Stakeholders involved in the development and review of this document include:

• Missouri Health Care Association • Missouri State Board of Nursing • BJC HealthCare • Missouri Department of Corrections • Missouri Department of Health and Senior Services' Bureau of Emergency Medical Services

The Missouri COVID-19 Vaccination Implementation Plan leverages local expertise and resources with state government support to accomplish three key objectives:

1. Arrest the morbidity and mortality of COVID-19 while reducing the stress on critical healthcare infrastructures. 2. Protect those at most significant risk of adverse events from COVID-19 and those critical to

accelerating economic recovery. 3. Provide vaccination at no cost to every Missourian desiring one.

We developed regional Vaccination Support Teams (VST) in each of the State's nine State Emergency Management Agency (SEMA) regions to achieve these objectives. These five-person teams contract with the State to provide direct support and oversight of COVID-19 vaccination efforts within their contracted region. Regional Implementation Teams (RIT), made up of local healthcare and community leaders, coordinate the local deployments of vaccinations with the support and guidance of the State implementation Team (SIT). Made up of representatives from the RITs and leadership from the Bureau of Immunizations, the SIT serves as a central coordinating group for information dissemination, problem-solving, sharing of best practices, and ensuring local voices are at the forefront of the statewide plan. Day-to-day oversight operations of the vaccination program lie with the Chief of the Bureau of Immunizations and an executive planning team able to rapidly and flexibly respond to changing pandemic environments while complying with federal and state guidelines.

Section 1: COVID-9 Vaccination Preparedness Planning

Program Planning Activities Upon receipt of August 4, 2020, COVID-19 Vaccination Planning August Letter to Health Departments:

• The Missouri Department of Health and Senior Services (DHSS) charged Bureau of Immunizations Chief Jennifer VanBooven, MPH, MA, to develop a statewide vaccination plan.

• DHSS established the Missouri Interagency COVID-19 Vaccination Planning Team to support VanBooven's leadership efforts and broaden collaboration, including ideas and strategies, to develop the plan. The team includes representatives from state and local government and community and professional organization representatives selected to provide emergency planning, social work, public health, and healthcare experience.

• To supplement the team's administrative support, SEMA requested military and medical planners from the Missouri National Guard to assist with initial planning for a phased deployment of COVID-19 vaccinations across Missouri.

The Interagency COVID-19 Vaccination Planning Team began meeting weekly in-person on August 26 with a conference call option to allow partners across Missouri to participate. To effectively address the myriad of planning issues, the team was divided into six "Lines of Effort (LoE)" for more in-depth discussions, idea generation, and planning. Each LoE comprises a team lead, a military planner, and engaged government and industry stakeholders.

The LoE teams met each week separately to conduct in-depth dives into their topical areas while holding weekly "Synchronization and Action" meetings to facilitate inter-LoE sharing and alignment efforts.

The groups' earliest tasks included reviewing a combination of existing emergency preparedness plans, after-action reports of previous outbreaks (notably a Hepatitis A outbreak in September 2019 that required a mass vaccination deployment), and engaging individuals previously participated in the planning and delivery of past emergency services. In addition to reviewing state influenza vaccination and biologic agent terrorism plans, the teams coordinated with local and county public health agencies to verify resources and capabilities. The groups also confirmed local knowledge of

"the situation on the ground" could be integrated into statewide plans, guaranteeing a flexible organizational approach. This early recognition of the situation as a complex adaptive system facilitated the development of executive intent to guide future decision-making.

Continuous Quality Improvement Efforts At each phase of plan development, the teams used constraint-based scenarios to refine traditional vaccination and response plans. As planning became more concrete, the planning team conducted weekly failure point analyses discussions, using an Observe-Orient-Decide-Act loop analytic process to identify critical nodes, decision points, and data requirements. This helped define decision- making authorities and establish working relationships to facilitate actions, including pivoting quickly in a changing environment. For example, Missouri originally planned to use the Vaccine

H1N1 Lessons and their COVID Vaccine Application • H1N1 Issue: Poor quality ancillary supplies shipped with vaccine

o COVID Mitigation Strategy: State is purchasing ancillary supplies (and PPE) to send to health care providers so that the vaccine campaign will not be slowed down.

• H1N1 Issue: Messaging and information flow to local partners was hampered by state leaders trying to craft perfect messages. o COVID Mitigation Strategy: State teams already made contact with 20+ external partners,

including LPHAs, and are convening an External Advisory Committee comprising community leaders with ties in the neighborhoods most in need

• H1N1 Issue: Initial distribution of antiviral medications done by using a standard “Pull Method”

Receive, Stage and Store site (RSS). o COVID Mitigation Strategy: Given centralized distribution, logistical issue will lessen.

Nonetheless, community tabletops will help troubleshoot the process.

• H1N1 Issue: Various issues and certain procedures caused gaps and access to care barriers that prevent individuals from receiving the recommended vaccines. o COVID Mitigation Strategy: DHSS Bureau of Immunization Assessment and Assurance (BIAA)

staff will utilize survey information developed by the State Epidemiologist that is designed to determine gaps and access to care barriers that prevent individuals from receiving the recommended vaccines. Following completion of the survey, DHSS will host a gathering of LPHAs and other public health stakeholders to discuss the results of the survey and develop a plan of action to address the gaps identified.

Administration Management Systems (VAMS) for vaccination efforts in Phase 1. After working through the onboarding process, the teams identified this would cause providers to onboard two systems (one system for Phase 1 and another system for Phase 2 and 3). Therefore, we chose to use Missouri's immunization information system (IIS).

Upon finalizing the initial statewide COVID-19 vaccination plan, the implementation team will continue to "stress test" the plan, expanding to include real-time involvement of vaccinators, logistical partners, and technical interfaces. DHSS will execute conducting a comprehensive real-time exercise on Thursday, December 3rd.

The State takes a regionally-empowered model, supported by a team of State experts, and

advised by the communities most vulnerable to COVID

Section 2: COVID-19 Organizational Structure and Partner Involvement

Organizational Structure and Teammates- From Planning to Implementation While the Interagency COVID-19 Vaccination Planning Team's initial organization and the structure were discussed in Section 1, it is essential to highlight the transition of the majority efforts from initial planning to implementation. This transitions from the current collaborative planning effort to a need for full-time staff dedicated to the phased- execution of Missouri's COVID-19 vaccination program. The recent planning effort relies on the part-time attention of six teams composed of 75+ state employees, 10 Missouri National Guard planners, and 50+ external non-state partners. An executive planning team (EPT), State Implementation Team (SIT), Regional Implementation Teams (RIT), and Vaccination Support Teams (VST) will guide future efforts.

Success on the ground requires behind-the-scenes work—SET

fulfills this role

Those on the ground know best, so RIT will operate within the community in each region

Coordination of external and internal efforts occurs regularly

under the unified SIT

The RITs team of experts will cover the entire State—serving alongside those that know the

communities best

The EPT ensures that significant operational adaptations to the state COVID-19 vaccination plan occur within a continually changing environment. Led by the Chief of the Bureau of Immunizations, it includes both state COVID-19 response leadership and topical leads from each of the implementation LoEs:

1. Vaccine Providers. 2. Populations to be Vaccinated. 3. Process and Logistics of Vaccination. 4. Information Technology/Interfacing.

An expanded team, including the EPT, makes up the State Implementation Team (SIT). SIT is responsible for overseeing and implementing the effective deployment of Missouri's COVID-19 vaccination plan and providing critical services, such as IT support, vaccine distribution planning, and sharing of best practices between Regional Implementation Teams (RIT).

Early in the planning process, the Bureau of Immunizations recognized the strength of local healthcare and public health communities. The COVID-19 vaccination plan supports this local empowerment by establishing and supporting Regional Implementation Teams (RIT). Within each of the nine SEMA regions, the RIT comprises a state Bureau of Immunizations liaison, local healthcare providers, local community organizations, and a contracted regional COVID-19 Vaccination Support Team (VST).

Regional VSTs are composed of a contracted executive, registered nurse, two licensed practical nurses, and a communicable disease/public health specialist. VSTs will be established through an open competitive bid process, allowing each region to propose the partners most able to support local success, whether a local public health agency, a healthcare system, existing quality improvement organizations, or private contractors. This regional support structure facilitates a useful span of control for state actions while empowering local authorities and ensuring the personal relationships needed during an emergency response can be maintained and nurtured. It also provides trusted community leader involvement in local vaccination rollout planning.

Initial participants within the planning process who will be transitioning to the EPT, SIT, or RITs include the following:

Recruiting /Engaging Diverse Partners The State of Missouri actively engaged various organizations from the public, private, and nonprofit sectors during the planning process. This emphasis continued within the RITs, which will continue to outreach to obtain the broadest insights actively. Regional stakeholders are a crucial component of the RIT, including patient/population/community advocates, healthcare/social work providers, public health experts, emergency management directors, and industry representatives. This represents an inclusive and diverse group of stakeholder engagement and participation in the State's efforts to provide COVID-19 vaccination to all citizens. DHSS will also pay close attention to historically underrepresented populations and those at the most significant risk of morbidity and mortality from COVID-19 infection across regions.

RITs will organize their efforts around five revised LoEs:

1. Vaccine Providers. 2. Populations to be Vaccinated. 3. Process and Logistics of Vaccination. 4. Information Technology/Interfacing. 5. Communications.

These LoEs facilitate problem-solving and work on continued outreach within each of these five critical areas. Using the RIT model, each region can customize its outreach to reflect its unique circumstances and guarantee local experience inclusion into implementation efforts. Initial additional participant targets include the following:

LoE Focus Areas LoE 1 Vaccine

Providers LoE 2 Vaccinated

Populations LoE 3

Process/Logistics

LoE 4 IT/Interface LoE 5

Communications

Nursing Schools

Area Agencies on Aging

Pharmacies

Electronic Health Record

Companies

Local Community

Leaders

Dental Association

Homeless Advocates

UPS

Health Information Exchanges

Clergy

Medical Schools

Clergy

Medical Vendors

Organizations Serving Minority

Populations

EMS Agencies Local Community Leaders

Home Health Agencies NAACP

Note: The above lists are NOT exhaustive.

Section 3: Phased Approach to COVID-19 Vaccination

Missouri's planning efforts are based upon CDC guidance to anticipate a phased availability of vaccines within the State. The planning team delved deeper into the tiered-vaccination priorities currently published by those organizations, including the mismatch of early vaccine availability to the number of individuals needing to be vaccinated, the demands of ultra-cold storage the numbers of affected Missourians in each tier of prioritization. These challenges make the sequencing of vaccine distribution critical to our State's early success. Recognizing the continually changing situation and the need to provide flexible guidance for decision-making, the Governor's office has provided an executive intent around each phase of vaccine availability. The plan expands on the application of these principles in Section 4.

CDC’s original guidance (figure above)

How the State translated the guidance (figure above)

Phase 1 Missouri's Executive Intent is to "Reduce the morbidity and mortality of COVID-19 within Missouri while reducing healthcare system stress." To achieve this, Missouri plans to follow the CDC, Advisory Committee on Immunization Practices (ACIP), National Academies of Sciences, Engineering, and Medicine (NASEM) guidance and begin the vaccination efforts by targeting unpaid and paid healthcare workers in Phase 1A.1 Missouri plans to collaborate with healthcare systems, pharmacies, and community partners to vaccinate long-term care facility staff and other healthcare workers. If the need arises to break this group further down, Missouri plans to start with healthcare staff at long-term care facilities.2 Again, if vaccine supply forces prioritization, the next step is healthcare workers who self-identify recognized CDC established comorbidities for COVID-19, starting with inpatient healthcare workers expanding out to outpatient healthcare workers. These vaccinations will take place in closed Points of Dispensing (PODS). NOTE: This is still all occurring in Phase 1A.

Missouri will then move into phase 1B, working with local and community partners to begin vaccinating critical infrastructure workers and Missourians at higher risk for COVID-19 disease identified by the CDC established comorbidities for COVID-19 (details are in Section 4 Critical Populations). Missouri will collaborate with a RIT to work with community partners to vaccinate those in Phase 1B. Local healthcare providers, community organizations, their partners, and local public health agencies will perform these vaccination efforts in PODs where possible.

Phase 1B: Potentially limited supply of COVID-19 vaccine doses available AND long-term care residents recommended to receive vaccine. Pharmacy Partnership for Long-term Care (LTC) Program:

Missouri plans to participate in the pharmacy partnership for Long-term Care Program coordinated by CDC.

• Partner through CDC’s Pharmacy Partnership for LTC Program for COVID-19 Vaccine to provide on-site vaccine clinics for residents of long-term care facilities (LTCFs) and any remaining LTCF staff who were not vaccinated in Phase 1-A. The Pharmacy Partnership for Long-term Care Program provides end-to-end management of the COVID-19 vaccination process, including close coordination with jurisdictions, cold chain management, on-site vaccinations, and fulfillment of reporting requirements. The program will facilitate safe and effective vaccination of this prioritized patient population, while reducing burden on facilities and jurisdictional health departments.

o This program is free of charge to facilities. The pharmacy will: Schedule and coordinate on-site clinic date(s) directly with each facility. Three visits

over approximately two months are likely to be needed to administer both doses of vaccine and vaccinate any new residents and staff.

Order vaccines and associated supplies (e.g., syringes, needles, personal protective equipment).

Ensure cold chain management for vaccine. Provide on-site administration of vaccine.

1 Phase 1A Definition: Paid and unpaid people serving in health care settings who have the potential for direct or indirect exposure to patients or infectious materials and cannot work from home 2 Missouri Long Term Care Facilitates encompass Skilled Nursing Facilities, Intermediate Care Facilities, Assisted Living Facilities, Residential Care Facilities, Immediate Care Facilities for Individuals with Intellectual Disabilities, and Adult Day Care

Report required vaccination data (approximately 20 data fields) to the local, state/territorial, and federal jurisdictions within 24 hours of administering each dose.

Adhere to all applicable CMS requirements for COVID-19 testing for LTCF staff. o If interested in participating, each facility should sign up and indicate their preferred partner

from the available pharmacies. Skilled nursing facilities and assisted living facilities will indicate which pharmacy

partner (one of two large retail pharmacies or existing LTC pharmacy) their facility prefers to have on-site (or opt out of the services) between October 19–October 30.

• SNFs will make their selection through NHSN beginning October 19. • An “alert” will be incorporated into the NHSN LTCF COVID-19 module to

guide users to the form. ALFs will make their selection via online REDCap sign-up form. The online sign-up information will be distributed through ALF and SNF partner

communication channels (email, social media, web). After November 1, 2020, no changes can be made via the online forms, and the

facility will have to coordinate directly with the selected pharmacy provider to make any changes in requested vaccination supply and services.

Indicating interest in participating is non-binding and facilities may change their selection (opt-out) if needed.

CDC will communicate preferences to the pharmacy partners and will attempt to honor facility preferences but may reassign facilities depending on vaccine availability and distribution considerations, and to minimize vaccine wastage.

o CDC expects the Pharmacy Partnership for Long-term Care Program services to continue on-site at participating facilities for approximately two months.

o After the initial phase of vaccinations, the facility can choose to continue working with the pharmacy that provided its initial on-site clinics or can choose to work with a pharmacy provider of its choice.

Phase 2 Missouri's Executive Intent is to "Secure the critical infrastructure of Missouri and accelerate economic recovery within the state." To accomplish this, Missouri will use the RITs to collaborate with local community partners to vaccinate those in Phase 1 who could not be vaccinated. We will also vaccinate populations at increased risk of acquiring or transmitting COVID-19. These populations of consideration include racial and ethnic minority groups, housing-insecure individuals, people living and working in congregate settings, and other groups and other communities at higher risk of severe outcomes from COVID-19. The staff of manufacturing facilities identified as critical infrastructure or critical to national security is, by definition, essential to the economy and safety of the State as part of Phase 2.

Missouri compiled information about these critical populations through the Pandemic Influenza Preparedness Tier Worksheet. The RIT will be working with local and regional partners to promote equitable and efficient uptake of the COVID-19 vaccine to reach these populations. The RIT will use onsite PODs and mass vaccination clinics as needed. Missouri will also prepare to vaccinate the general public depending on vaccine quantities and continue providing a regional approach to vaccinating the rest of its population.

Federal Direct Allocation to Pharmacy Partners:

Missouri plans to participate in the federal direct allocation to pharmacy partner strategy coordinated by CDC.

• Vaccine will be allocated and distributed directly to select pharmacy partners from the federal government.

o Direct allocation opportunities will be provided to retail chain pharmacies and networks of independent and community pharmacies3 (those with a minimum of 200 stores). All partners must sign a pharmacy provider agreement with the federal government.

o Once the list of federal partners has been finalized, CDC will share the list with jurisdictions. o On a daily basis, pharmacy partners must report to CDC, the number of doses of COVID-19

vaccine a) ordered by store location; b) supply on hand in each store reported through VaccineFinder, and c) number of doses of vaccine administered to individuals in each state, locality, and territory.

• Pharmacy providers will be required to report CDC-defined data elements related to vaccine administration daily (i.e., every 24 hours). CDC will provide information on these data elements and methods to report if stores are not able to directly provide data to jurisdiction IISs.

• All jurisdictions participating in this program will have visibility on number of doses distributed to and administered by each partner store.

• Jurisdictions will be given contact information for each partner participating in this program if they have any questions or concerns related to distribution of vaccine to stores in their jurisdiction.

Provider enrollment will continue to be a priority in Phase 2.

3Pharmacy services administrative organizations, or PSAOs

Phase 3 Missouri plans to continue vaccination efforts in this phase with individuals identified in Phases 1 and 2. The State of Missouri will focus on making sure every Missourian who qualifies and needs or wants a COVID-19 vaccine receives the requested vaccine at no cost.

The intention is federally qualified health centers, rural health clinics, private providers, and pharmacies take on the majority of the vaccination effort for most adults in their areas. Local public health authorities and the state health authority will target vaccination efforts toward the most vulnerable populations, such as homeless populations with limited access to care and local incarcerated individuals, and assist with college and university vaccination efforts.

For this effort, Missouri plans to use a state mobile medical unit, as needed or requested, staffed with a DHSS team dedicated to that mobile vaccination unit. The mobile unit will devote days and times in various locations to provide the COVID-19 vaccine to at-risk populations. State health authorities will work with local health authorities and community organizations to identify vaccination sites and communicate available vaccination days to the population. Community partners will need to identify other resources for vaccinating hard-to-reach populations. This will also help local and State health authorities to provide vaccinations to outbreaks in these communities.

Missouri will continue to support private providers, federally qualified health centers, rural health clinics, and pharmacies in their vaccination efforts. Vaccination supplies, vaccines, and appropriate PPE will be available, so cost is not a barrier to patient vaccination. Additionally, during this phase, Missouri will work toward routine annual vaccination for the qualifying population. Missouri also will continue to require all COVID-19 vaccine providers to register with Vaccine Finder.

Missouri's Bureau of Immunizations (BI) will continue to educate providers on the importance of working with providers on presumptive recommendations for COVID-19 vaccine, on notifying adverse events in VAERS, and continuing to recruit additional providers, especially in specialty clinics, such as geriatrics, endocrine, cardiac, pulmonary and kidney clinics, rural health, and independent pharmacies. BI will continue to monitor COVID-19 vaccine orders by assessing monthly ordering reports supplied by the vaccine ordering manager. BI will also consider monthly vaccine wastage reports provided by the vaccine-ordering manager to assure minimal waste. Finally, BI will provide COVID-19 vaccine administration reports to CDC as requested. BI will continue with a centralized reminder/recall for the second dose and annual COVID-19 vaccine.

Section 4: Critical Populations

Identification & Quantification of Critical Populations Early in the COVID-19 vaccination program, the Bureau of Immunizations anticipates the supply of the COVID-19 vaccine will be limited. The planning team reviewed information from the CDC's Advisory Committee on Immunization Practices (ACIP), the National Institutes of Health (NIH), and the National Academies of Sciences, Engineering, and Medicine (NASEM) to provide recommendations for priority vaccination. The intent informed the planning team's guidance of the COVID-19 Vaccination Program, assumptions for vaccine delivery and storage, and knowledge of Missouri's population and critical infrastructure.

Research from COVID-19 data collected to date has shown that obesity (BMI ≥ 30), chronic kidney disease, chronic obstructive pulmonary disease (COPD), diabetes, hypertension, and chronic heart disease are associated with a higher risk of severe COVID-19 illness.1 2 Nearly 90% of hospitalized adults had at least one high-risk medical condition, and more than 60% had three or more.1 Furthermore, adults ≥65 years old represent 80% of COVID-19 deaths and have the highest cumulative rate of COVID-19 associated hospitalizations. Older age is the most potent independent risk factor for in-hospital death.1 3 Statistics have also revealed racial and ethnic minority groups account for 60% of COVID-19 cases and 50% of COVID-19 deaths, although racial and ethnic minority groups only represent 40% of the total US population.4 ACIP identified factors—e.g., lack of healthcare access, working in higher-risk occupations, education, income gaps, and living in crowded housing areas—that may increase the risk of contracting COVID-19.4

ACIP has not yet provided formal recommendations for vaccine prioritization. However, current guidance discusses the inclusion of ethics and equity as part of the process.5 ACIP reviewed three frameworks for early COVID-19 vaccine allocations that incorporate ethics and equity in the process, which the planning team also reviewed. All identify frontline healthcare personnel in the initial phase of vaccine allocation and those at significantly higher risk (≥ 2 underlying medical conditions) and ≥ 65 years of age.5The frameworks were less consistent with the placement of essential workers. For example, the National Academies placed police and fire workers in Phase 1A, and Johns Hopkins placed them in Tier 2.

The most recent CDC guidelines for prioritization follows:

• Phase 1A "Paid and unpaid people serving in healthcare settings who have the potential for direct or indirect exposure to patients or infectious materials and cannot work from home."

• Phase 1B "People who play a key role in keeping the essential functions of society running and cannot socially distance in the workplace (emergency and law enforcement personnel, food packaging and distribution workers, teachers/staff, childcare providers, etc.) and people at increased risk for severe COVID-19 illness, including people 65 years of age or older."

After reviewing all prior information described above, the COVID-19 planning team has identified the following population as priority groups for vaccination in Missouri:

• Phase 1A: All healthcare personnel and staff who have the potential for direct or indirect exposure to COVID-19 and are unable to work from home.

Source: CISA

• Phase 1B: Those at increased risk for severe COVID-19 illness, including those ≥ 65 years of age, those with chronic illness, and those workers who are vital to keeping the essential functions of society running.

Essential workers were identified using the Critical Infrastructure Sectors.6 The Cybersecurity and Infrastructure Agency (CISA) defines Critical Infrastructure Sectors as "sectors whose assets, systems, and networks, whether physical or virtual are considered so vital to the United States that their incapacitation or destruction would have a debilitating effect on security, national economic security, national public health or safety, or any combination thereof." 6 The Occupational Safety and Health Administration (OSHA) further classifies each job as low risk to very high risk of COVID-19 exposure based on the type of duties and the need to contact within 6 feet of people known to be suspected of being diagnosed with COVID-19. A majority of jobs that fall in the high-risk to very high-risk exposure category are also considered critical infrastructure jobs. Note: Education is not currently shown on the graph below but is regarded as a critical infrastructure sector.

DHSS obtained estimated numbers of priority groups for COVID-19 vaccination using data from the Bureau of Labor and Statistics, DHSS, CDC mapping tools, Missouri Economic Research and Information Center (MERIC), and Missouri Department of Economic Development. DHSS sent county-level tier sheets to each Local Public Health Agency (LPHA) for completion, with 14% of LPHAs not returning tier sheets. Many of the produced sheets had missing or apparent inaccurate data. Members of the planning team have reached out to those who did not return the document or had missing data. State-level data are included below. The maps in Appendix D will consist of locations of priority groups by county

Subset Sequencing Strategy Using information described in Section 4A, the Missouri Interagency COVID-19 Planning Team has determined the following priority groups for vaccination sequencing. If insufficient vaccine supply requires further tiering, this will be done by limiting the described populations to those who are ≥ 65 years old who are known to increase poor outcomes with COVID-19.

Estimated Number of Missouri Priority Population for Vaccination

Healthcare

First Responders

Adults ≥ 65 Adults w/high-risk

conditions

Childcare workers

~425,000

~31,000

~1,075,000

~1,295,000

~16,750

Teachers/ Staff

Water/ Wastewater

Energy

Manufacturing

Food/Ag Plant

~250,000 ~1,300 ~2,250 ~150,000 ~50,000

*Critical Manufacturing includes electrical equipment, appliance, and component manufacturing, fabricated metal product manufacturing, furniture, and related product manufacturing, machinery manufacturing, primary metal manufacturing, transportation equipment manufacturing: Source: EMSI 2020 Obtained from Missouri Department of Economic Research * Adults with high-risk conditions estimated by taking the population of 18-64 year-olds, 3,704,931 x 35%, the ~ average who have an underlying health condition.

Tier 1A Populations • How the CDC defines 1A: "Paid and unpaid people serving in healthcare settings who have

the potential for direct or indirect exposure to patients or infectious materials and cannot work from home."

• How Missouri defines 1A: All healthcare personnel and staff who have potential for direct or indirect exposure to COVID-19 and are unable to work from home.

1A Priority Population Subset Rationale

Skilled Nursing Long Term Care Assisted Living

Residential Care Facility Staff

Population estimate: ~60K

The highest risk population for mortality from COVID-19 is nursing home residents, with 75% of the MO COVID-19 deaths occurring within these

facilities. Visitor restrictions and new resident quarantine protocols have limited the exposure route to staff unaware of early infection. The

addition of vaccination to the team, PPE, and screening protocols has been modeled by the CDC to result in the most significant reduction in COVID-

19 deaths by reducing/eliminating the introduction of infection into these congregate living facilities.

Patient-facing Inpatient and

Outpatient Healthcare Personnel with Underlying Health Conditions

(Examples: Hospital-based Physicians, Nurses, Aides, Therapists, Clinical Area Janitorial Staff,

Patient Reception Clerks, etc.)

Population estimate: ~85K

Healthcare workers with asthma, chronic obstructive pulmonary disease (COPD), diabetes, BMI ≥ 30, hypertension (HTN), chronic kidney disease (CKD), and chronic heart disease (CHD) are more susceptible to COVID infection, early asymptomatic spread to patients, and more significant morbidity of infection. Vaccination of these individuals will serve a dual

purpose of reducing the potential for infectious spread from medical staff to patients and eliminate/reduce their duration of illness, ensuring critical healthcare staffing availability, and returning them to care activities more

rapidly.

ALL REMAINING Patient-Facing Healthcare Workers

(Examples: Inpatient and Outpatient Physicians,

Nurses, Aides, Therapists, Clinical Area Janitorial Staff, Patient Reception Clerks, etc.)

Population estimate: ~125K

The remaining healthcare critical infrastructure personnel are equally at risk for infection and are essential for ongoing healthcare capacity.

Note: All examples provided are not exhaustive. Moreover, they are not mentioned explicitly in the order they will receive the vaccine. Vaccine administration within these prioritized populations will take into account numerous variables. The vaccination process will be as transparent as

possible and directly involve the populations above.

Tier 1B Populations • How the CDC defines 1B: "People who play a key role in keeping the essential functions of

society running and cannot socially distance in the workplace (emergency and law enforcement personnel, food packaging and distribution workers, teachers/staff, childcare providers, etc.) and people at increased risk for severe COVID-19 illness, including people 65 years of age or older."

• How Missouri defines 1B: Those at increased risk for severe COVID-19 illness including those ≥ 65 years of age, and those workers who are vital to keeping the essential functions of society running.

1B Priority Population Subset Rationale

Public-Facing Public Health Workers

These individuals are critical to implementing the State's COVID-19

response while directly engaging the public.

First Responders

(Examples: non-hospital EMS, Law Enforcement Officers, Fire and Correction personnel)

Personnel within this category provide essential emergency services that mostly cannot be performed virtually. As a result of these duties, they

have unavoidable potential exposures that threaten both their well-being and the community they cannot serve during illness. Accelerated

economic recovery and the provision of essential government services require the performance of these duties.

Additionally, inmates' confined nature has been amenable to procedural controls to reduce the likelihood of correctional facility outbreaks. As a result, staff now represent the most likely source of a facility outbreak.

Vaccination of corrections staff can vastly reduce this source of potential attacks.

High-Risk Individuals including those

65 Years of Age and Older

Individuals with comorbid health conditions retain an elevated risk for mortality and morbidity due to their condition's nature. Those not covered

by previous categories should receive priority for vaccination before general population vaccination in a limited vaccine environment. They

have a more significant potential impact on vaccination.

Childcare Workers

Childcare workers represent a crucial enabler of economic activity while having similar exposure risk to that identified for teaching staff. Their immunization serves the dual role of personal protection and allowing

Missouri residents to return to work.

Teachers/Staff

Society has highlighted the critical role of the public school system during the COVID-19 pandemic. School personnel, regardless of duties, are at a higher risk of exposure due to significant social distancing challenges in

minority populations. Disease within this population has the dual impact of personal and societal impact due to the lack of suitable alternative

educational options in their absence. The inability to conduct in-person schooling has a recognized secondary effect on parental employment

capabilities, making the ability to reopen schools a necessary prerequisite to accelerated economic recovery.

Select State Emergency Management & Emergency Public Work Employees

Critical to the State's response in times of emergency—e.g., hazardous weather conditions like flash floods and severe snow effects—this select subset of the State's workforce runs the State's Emergency Management

infrastructure and keeps vital public utilities and services operational.

Drinking Water-Wastewater Facilities

Water purification and wastewater treatment facilities and the staff necessary to run them are critical for residents' safety, well-being, and a

significant economy.

Energy

The personnel who provide our residents and businesses with uninterrupted electrical power and restoration capabilities following

damage are a necessary prerequisite for Missouri's accelerated economic recovery.

Critical Manufacturing

The staff of manufacturing facilities identified as critical infrastructure or critical to national security is, by definition, essential in the economy and

safety of Missouri and the nation.

Food/Ag Plants Mass facilities for the production or processing of food represent a critical economic component that has accounted for significant COVID outbreaks

and the potential for food insecurity.

Employer-defined "Essential

Employees"

Employees identified by their employers as "essential employees" (typically applied during weather emergencies) are essential to their

employers' effective operations and the role that company plays within our communities and economy.

Note: All examples provided are not exhaustive. Moreover, they are not mentioned explicitly in the order they will receive the vaccine. Vaccine administration within these prioritized populations will take into account numerous variables. The vaccination process will be as transparent as

possible and directly involve the populations above.

The Bureau of Immunizations determined our earliest population (long-term care facility workers) to includes a majority female population with non-Hispanic Black employees at a higher rate than in the general populace. Remaining healthcare personnel has ~40% of individuals with either a high- risk healthcare condition (beyond occupational risk) or age ≥ 65.

Engaging Critical Populations As discussed in Section 2, the COVID-19 Vaccination Program SIT/RITs will continue equitable access to vaccinations, obtaining further information about populations within Missouri's counties, and informing future logistical requirements for providing access to COVID-19 vaccination services. Section 15 describes the monitoring efforts used to make sure SIT/RIT members proactively recognize populations that may not be adequately engaged or reached throughout the implementation.

For additional Information: Appendices include Population Targeting Maps

Section 5: COVID-19 Provider Recruitment and Enrollment

As part of its initial efforts, the planning team identified potential vaccinators through a multi-step process. These key steps were to identify potential providers, effectively engage them, effectively and rapidly enroll them into the program, and sustain their ongoing participation within COVID vaccination efforts.

DHSS first identified providers already participating within state vaccination programs and with validated interfaces with the state IIS (minimizing technology challenges or delays in initial phases). Concurrently, the planning team developed a provider education FAQ. This was paired with an electronic site survey designed to prescreen potential vaccinators through self-identification of interest while providing state planners with real-time information about potential vaccinators' locations and capabilities. Those targeted professionals included hospital systems, primary care providers, volunteer organizations, occupational health programs, Department of Corrections, and local public health departments. Within the first 96 hours of the survey deployment, the planning team received more than 400 responses, which will continue to guide planning and implementation efforts.

The development and deployment of an electronic provider agreement allow for a simple collection and reporting of enrolled-provider data, delivered in various formats. Additionally, initial vaccinators will mainly come from institutions with established vaccination programs and verified state IIS interfaces. By pursuing this strategy, early monitoring and reporting capabilities can use standard dashboards and reporting modules within the ShowMeVax system (CSV reports can be pulled and sent to the CDC twice weekly). As additional providers are brought on board, those providing COVID vaccinations will receive prioritization for interfacing verification within ShowMeVax and immediately identify within the electronic provider agreement system.

Vaccinator Identification

Vaccinator Engagement

Vaccinator Enrollment Vaccinator Sustainment

Trending/Reporting Info

Regular Updates

Vaccinator Micro-site

Logistical Support

Documentation Plan

License Verifications

Provider Agreements

Site Survey

Vaccinator Micro-site

FAQ Responses

Expand Awareness

Targeted Locations

Pharmacy Chains

Hospital/Health Systems

LPHAs

Current ShowMeVax Providers

Provider Validation As efforts transition from planning to implementation, identified providers will complete an online version of the provider agreement, which will then undergo a three-stage validation process within DHSS to validate licensure and disciplinary history. As part of the provider agreement, the Chief Medical Officer (CMO) and Chief Executive Officer (CEO) will provide a list of all prescribers involved with the vaccine administration. The CMO and all prescribers will have their licensures verified by the Bureau of Immunization staff using the information provided by the Board of Healing Arts, Board of Pharmacy, Board of Nursing, and DHSS Bureau of Emergency Medical Services (EMS) as applicable. The CMO and CEO/CFO signing the provider document are responsible for confirming those administering the vaccine have received appropriate training and have relevant and current credentials/privileges to administer the vaccine. Any MOUs required for the healthcare professionals administering the vaccine must be in place before using any healthcare professionals who would need an MOU.

Initial Vaccine Providers/Location for Critical Populations Once the details of initial vaccine receipt are known (vaccine type, potential arrival date, number of doses, etc.), the SIT will use the population sequencing tiers in Section 4 and the notification details to determine initial delivery sites. In preparation for this notification, the SIT will conduct several tabletop exercises before November 2020. To continue to refine the vaccine-allocation decision- support tool, the team will facilitate the rapid determination of appropriate allocations. While all Phase 1 vaccinator sites are expected to be prepared for delivery of vaccine within 24 hours of notification, the first potential delivery of vaccines will be additionally validated via phone to guarantee no circumstance changes might place the delivery in jeopardy.

Provider Training A vital component of the provider-facing website discussed in Section 12 is the ability to provide a "one-stop-shop" for Missouri COVID-19 vaccination providers. Missouri will set up a provider- dedicated webpage with real-time updates and links to becoming a COVID-19 vaccine provider, downloadable vaccination consent, VAERS reporting information, just-in-time CDC vaccination training, and CDC COVID-19 vaccine materials, including storage and handling information. Also, Missouri will provide vaccine administration materials to avoid vaccine errors and ensure proper vaccination technique with CDC established materials. Finally, the website will be augmented by active outreach mail and other materials to ensure awareness and drive vaccinators to necessary training.

Vaccine Redistribution Strategy/ Principles The planning team wants to minimize vaccine redistribution and reduce waste associated with temperature variations during transport. To accomplish this, the team is currently planning to distribute an ultra-cold vaccine only within major metropolitan areas (unless otherwise

recommended by CDC). Additionally, the team will provide only to organizations that sign an agreement to give vaccination to all-qualified-comers, including employees of other healthcare systems within their geographic region. Additionally, the team expects mobile vaccination teams within the nine Missouri regions to limit the need for redistribution beyond the original recipient of vaccines.

Should redistribution be requested or felt necessary, the provider will communicate the request to the Bureau of Immunizations, determining such a redistribution's acceptability. If determined appropriate, the Bureau of Immunizations will validate the Supplemental COVID-19 Vaccine Redistribution Agreement and transfer the vaccine under positive control, maintaining temperature data-logging throughout the process. The Bureau of Immunizations will determine on a case-by-case basis whether vaccines are directly transferred between providers or transferred from one site to another by Bureau of Immunizations personnel.

Equitable Access to Vaccines The planning team has compiled an extensive collection of maps identifying a wide variety of demographic and social risk factor distributions across the State of Missouri. While many of the distributions mirror the general population distribution across Missouri, it is imperative unrecognized or historically underserved populations at elevated risk be identified and served appropriately. In addition to the population-based demographic information, the survey deployed by the planning team included efforts to identify underserved populations for prioritization, as appropriate, guaranteeing equity in vaccine distribution. Missouri's RITs will develop further plans to reach at-risk populations and people of color in their identified regions. The RITs will supply the Bureau of Immunizations with the plans to assure equity is achieved. The RITs will also partner with medical schools in both the Kansas City and St. Louis metropolitan areas to leverage existing outreach clinics into the homeless, minority, and underserved populations to deliver the vaccine via existing, trusted entities. To effectively monitor these impacts, it is imperative demographic information be available and included in ongoing programmatic dashboards shared with the implementation team.

Community-based (non-chain) Pharmacies While federal discussions about the potential deployment of vaccines via large pharmacy chains are ongoing, it is unclear to what extent this will penetrate many rural areas within Missouri. To clarify this impact, the Missouri Pharmacy Association distributed the planning team's survey, which included questions about the association of local pharmacies with national chains or associations that might be involved in federal efforts. Upon receiving this information, the implementation team will actively outreach to those local pharmacies for potential inclusion as vaccinator sites to augment rural vaccination capacity through its existing relationship with the Missouri Pharmacy Association. Additionally, members of the Interagency COVID-19 Vaccine Planning Team have been part of webinars for the Missouri Pharmacy Association and Missouri Board of Pharmacy to encourage pharmacies to become vaccinators.

Section 6: COVID-19 Vaccine Administration Capacity

Theoretical Approaches to Vaccination Capacity CDC's Playbook defines vaccine administration capacity as "the maximum achievable vaccination throughput regardless of public demand for vaccination." Our planning team conducted time- motion analyses of multiple vaccine delivery strategies and settled on three primary approaches to use in capacity modeling: 1) Single Vaccinator, 2) Expandable Drive-Thru Lane, and 3) Gymnasium Mass Vaccination Event. These strategies took into account expanded infection control requirements/hygiene, vaccination preparation and delivery, documentation, and post-vaccination patient observation periods. The potential throughput of each process presented below:

Single Vaccinator Drive-Thru Gymnasium

Description

A single individual dedicated to providing vaccinations. May be

accomplished parallel to physician office visits or

as a dedicated onsite vaccinator

An available 14' x 85' drive- thru lane performs all aspects of screening/

vaccination/observation without leaving the vehicle. Assumes one vaccinated per

car (# in a vehicle has minimal impact on time, but

dramatically increases throughput). Additional

lanes are additive to volume.

A 94' x 50' basketball court allows 16

vaccination lanes while maintaining 6' social

distancing. The limiting factor is likely to be

parking availability and safely keeping social

distancing outside the facility's controlled

area.

Throughput Max = 10 doses/hour Avg = 48 doses/8 hr day

Max = 12 doses/hour Avg = 94 doses/8 hr day

Max = 160 doses/hour Avg = 1,280 doses/8 hr

Required Staffing

1 Clinical FTE 4 Clinical FTE 3 Non-Clinical FTE

20 Clinical FTE 30 Non-Clinical FTE

The three strategies' development provides future planners with the option to target vaccination efforts and respond to environmental drivers of methodology (such as severe weather in Missouri in winter and spring).

Practical Application to Vaccine Availability Scenarios Using the above Vaccination Capacity Modeling, the planning team has calculated the "Days to Complete Vaccination" for each county in Missouri. This calculation is currently based upon the premise that each eligible Primary Care Physician in the county would devote one individual in their office to full-time vaccination duties. This throughput is then compared to the county's total population, providing a rough estimate of the days of work required to vaccinate the county fully. This calculation is based on assumptions and has apparent challenges. Still, it has allowed the planning team to identify those counties and communities within the State who WILL NOT have the ability to likely self-vaccinate with

their local healthcare resources. As a result, the State knows the areas that likely require augmentation with external vaccinator resources. We will use this knowledge to estimate what help is necessary within these communities before moving to the next.

The storage, handling, and administration requirements of ultra-cold vaccines have presented a logistical challenge to the planning team. As a result of these challenges, those ultra-cold doses will likely need to be targeted within Kansas City and St. Louis (unless otherwise recommended by CDC). Although vaccination capacity exists to use the 975-dose minimum orders and complicated storage requirements, extended availability of ONLY ultra-cold vaccine could undermine the tiered sequencing currently planned to guarantee equitable vaccine distribution across rural and urban populations.

Vaccination Capacity Modeling demonstrates it would take a minimum of 331 days of gymnasium events to vaccinate all Tier 1A healthcare workers statewide. This model's apparent failure demonstrates the crucial role of concurrent efforts across Missouri and the importance of decentralized execution.

Impact of Vaccination Capacity Modeling on Provider Recruitment

The planning team is in the process of combining the results of the days-to-completion vaccination capacity modeling and the initial survey results identifying potential willing vaccinators to create a real- time map of vaccination capacity across Missouri. As mentioned above, this map will show planners where to deploy augmentative vaccination teams and where to focus recruitment efforts for additional local vaccinators.

For additional Information: Appendices include Satellite and Curbside Vaccination Site Info

Section 7: COVID-19 Vaccine Allocation, Ordering, Distribution, and Inventory Management

Vaccine Allocation Strategy The primary factors driving vaccine allocation in the vaccination plan's initial phases are the vaccine's type and volume. Even with additional sequencing to reduce initial populations, Tier 1A vaccinations are expected to require multiple vaccine supply months. The potential need to limit ultra-cold vaccinations to major metropolitan areas would likely require much of the initial doses to be allocated to those geographic areas, and vaccinations are provided onsite at large medical centers. As vaccine availability increases, the ability to deploy regional immunization teams and leverage LPHA vaccination clinics will expand geographic allocation. However, tiered delivery to populations is expected to continue for up to six months after vaccinations initiation (depending upon availability). The Bureau of Immunizations will monitor vaccine allocation in real-time and regularly report to the implementation team to ensure the allocation process's transparency and provide feedback on potential next steps. DHSS will use the ongoing evaluation of the vaccination program against the Governor's Executive Intent to drive decision-making.

Cold-chain Storage Assessment/ Planning Impacts As discussed previously, the deployed site survey of potential vaccinators included site-specific information about vaccine storage and monitoring capabilities at potential sites the State will use when placing orders into VTrckS. While the initial impression is that much of the ultra-cold capacity is confined to major metropolitan areas, the team will continue to assess this factor as results become available. This requirement potentially will result in a significant variable impact on geographic vaccine distribution, particularly during Phase 1, limited availability operations. The Bureau of Immunizations will also apply the critical patient population information to ensure the vaccine is allocated to the areas defined in Section 4.

Vaccination Ordering Process The Bureau of Immunizations will maintain oversight for all aspects of the ordering of the COVID-19 vaccine and ensure the state allocation strategy is upheld. Using existing infrastructure, approved providers will place orders for the COVID-19 vaccine. The Bureau of Immunizations checks approved provider locations are entered into VTrckS. After receiving and approving an order, the Bureau enters the order into VTrckS, allowing shipment to the approved sites.

Unplanned Vaccine Redistribution As discussed previously, Missouri intends to limit the need for vaccine redistribution. However, recognizing the potential for an unforeseen need, the Bureau of Immunizations will use the existing emergency vaccine distribution plan. As part of this previously deployed plan, the Bureau of Immunization personnel will take custody of the vaccine and reposition the vaccine as necessary.

The Bureau's responsibility is to ensure the appropriate protections are taken to maintain the proper temperature levels and that any ancillary products supplied with the vaccine are also repositioned simultaneously. The Missouri State Highway Patrol can assist with security detail if the need arises.

Vaccine Wastage Monitoring Missouri's Bureau of Immunization integrated an established wastage process within the immunization registry, ShowMeVax (SMV). This process will notify the Bureau of Immunizations of vaccine wastage and monitor these reports for potential challenges to specific vaccinators or sites indicating the need for additional scrutiny. Pending further direction from CDC, providers may apply current recapture procedures to return vaccine doses that have either experienced a temperature excursion or are otherwise suspect for wastage to the Bureau of Immunizations.

Section 8: COVID-19 Vaccine Storage and Handling

Site-specific Issues Individual Provider Location

Individual provider locations will use the CDC Vaccine Storage and Handling toolkit until receiving the updated CDC toolkit with specific COVID-19 vaccine handling. Any temperature excursions will be managed following the state Vaccines for Children (VFC) program guidance and any additional supplementation provided by the CDC.

Satellite, temporary, or off-site settings For mobile, satellite, or temporary sites to receive the vaccine, the sites must assure cold storage. The Bureau of Immunizations will require the onsite point of dispensing manager to record temperatures every 30 minutes using a digital data logger and the off-site vaccination clinic checklist. SEMA currently has more than four mobile vaccine transport coolers used to transfer vaccine but has only four digital-data loggers.

Planned redistribution from depots to individual locations and from larger to smaller locations

At this time, Missouri is not planning to have vaccine depots. If this changes, Missouri will contract with commercial shipping platforms to transport vaccines from storage depots to providers when redistribution requirements exceed provider capabilities. The Bureau of Immunizations may use additional public transportation methods if an emergency redistribution situation arises. The commercial shipping platform needs to verify it can maintain a cold-chain.

Unplanned repositioning among provider locations Before the movement of any vaccine, providers must submit a request to the Bureau of Immunizations at which time the Bureau of Immunizations will provide the CDC redistribution form to the site. Before the approval of the movement of vaccines, cold-chain management must be secured.

Assessment of Provider/Depot Storage and Temperature Monitoring DHSS sent a preliminary site survey to providers before onboarding to assess the ability to sustain cold-chain management. The formal provider agreement will follow. Providers need to provide refrigeration/freezer certificates to the Bureau of Immunizations. Additionally, providers must review data-logging equipment logs regularly and upload them to SMV to validate compliance. Providers must record the minimum/maximum in the morning and the temperature once in the morning and once in the afternoon. Providers must upload the temperature logs into SMV the first day of the month for the previous month. DHSS will only allow sites to order vaccines if they can guarantee the appropriate temperature is maintained.

For additional Information: Appendices include Refrigerated / Frozen Vaccine Storage/Monitoring Info

Section 9: COVID-19 Vaccine Administration Documentation and Reporting

Existing Infrastructure While recognizing the appropriateness of both the state IIS and VAMS, early efforts within Missouri focused on recruiting providers with demonstrated data exchange with the state IIS, ShowMeVax (SMV). Using this strategy for initial recruitment allows the State to prioritize future vaccinators' enrollment not yet in the system without switching between documentation software. The contractor that provides ShowMeVax, Envision, is currently adding additional IZ Gateway (SMV) data feeds into the CDCs WebIZ interface, allowing Missouri to submit following the (IAW) CDC guidelines.

Provider Readiness / Documentation Signing and submitting the provider agreement obligates the organization's chief medical officer/chief financial officer to validate the provider’s readiness and compliance with reporting dose administration to the state’s immunization information system, ShowMeVax, within 24 hours. There are several options available to providers for documenting the required data elements of the COVID-19 vaccination to ShowMeVax:

• HL7 Interface • HL7 Batch Upload • Manual Entry

For consideration, if a provider isn’t documenting priority population administration in their electronic health record or hub, an HL7 batch upload or manual entry are the options for populating ShowMeVax. If a provider is not utilizing an electronic health record or hub, manual entry is the only option for populating ShowMeVax. Providers must contact the DHSS Reporting Team (immunizationhl7onboarding@health.mo.gov) to register their preferred method of populating ShowMeVax with COVID vaccine doses both for priority populations as well as clients prior to enrolling as a COVID vaccinator. Once registered, the Reporting Team will provide the appropriate implementation guides and how-to procedures.

Vaccination Delivery Monitoring The Bureau of Immunizations will regularly pull reports from SMV identifying how many vaccines have been administered and how much vaccine is on hand, as well as vaccination administration versus documentation entry timestamps. This will provide insight into accurate and complete documentation. If providers are non-compliant with the provider agreement, the Bureau of Immunization will send a provider's reminder. Failure to comply with the provider agreement may result in termination from the CDC COVID-19 Vaccination Program and criminal and civil penalties under federal law, including but not limited to the False Claims Act, 31 USC § 3729 et seq., and other related federal regulations, 18 USC §§ 1001, 1035, 1347, 1349.

mailto:immunizationhl7onboarding@health.mo.gov

Section 10: COVID-19 Vaccination Second-Dose Reminders

The complexity of multiple second-dose timing represents a potential confounder for both system design and public education. The Bureau of Immunizations has been using this strategy to ensure the infant/toddler vaccine series is complete. Missouri has extensive experience conducting a centralized reminder recall program. In addition to the centralized reminder/recall, Missouri will incorporate various other strategies outlined below.

Missouri will use a centralized reminder/recall system from SMV. To identify patients needing a second dose in the series, the Bureau will weekly run a list of patients with set parameters uniformly applied at 28 days. It will send reminders via postcard, email, or phone call to the vaccine recipient one week before the vaccination is needed. The Bureau of Immunizations will conduct follow-up reports twice a month to confirm two-dose compliance. Dedicated staff members will conduct a centralized reminder/recall.

Missouri will also encourage all clinics to schedule the next appointment before the patient leaves the clinic. This is an evidence-based strategy for achieving series completion. Missouri will also enable clinics and health systems to implement its patient reminder system or centralized reminders/recall.

For mobile mass clinic sites, Missouri will work with off-site providers, establishing a set schedule for communities using this service. The Bureau of Immunizations will ensure the centralized reminder system works in conjunction with this mobile mass clinic effort.

Additionally, providers will make sure each person will receive documentation at the time of vaccination. This will include the manufacturer name, lot number, dose, site, and date of vaccination for the patient's records and the date when the second dose is due.

Combining these evidence-based methods will help guarantee a two-dose completion.

Section 11: COVID-19 Requirements for IISs or Other External Systems

WebIZ/DUA Missouri has executed a data use agreement with the Association of Public Health Laboratories to participate in the Connect component of IZ Gateway. Missouri currently has a Memorandum of Understanding with Kansas to share immunization data between those two jurisdictions outside of the IZ Gateway. Missouri is now in the preliminary phases of having conversations with neighboring states about entering into Memorandums of Understanding to share immunization data in a means other than the IZ Gateway Share component. As the CDC releases its Data Use Agreement, Missouri will evaluate the DUA for compliance with Missouri legal requirements.

Data Exchange/Interface/Quality Monitoring In addition to a direct provider entry portal and the ability to ingest flat files, SMV has an established data exchange that currently accepts HL7v2.5.1 immunization messages from provider electronic health records (EHR). In coordination with both providers and the leading four EHR manufacturers in Missouri, standardized discrete data elements were identified to facilitate data exchange. This discrete data element structure enables the generation of standardized and ad hoc reporting of vaccinations recorded within the IIS and data warehouse.

New SMV providers are initially placed in a quality assurance (QA) environment until the Bureau of Immunization verifies their data accuracy. Once verified, the provider is migrated into SMV production via an HL7 message or a flat-file. SMV currently validates data against the federal data standard, which exceeds the CDC's requirements. In addition to the data's technical quality, the Bureau of Immunization staff conducts intermittent audits comparing vaccine inventory reporting against vaccine administration documentation. This can also be monitored at the provider level by comparing system timestamps of data entry versus reported administration times.

Provider Enrollment Strategy Although providers can use either SMV or VAMS in Phase 1, our provider engagement team targeted potential vaccinators with existing relationships and interfaces within the SMV system. A statewide network of existing providers without the requirement for significant additional IT onboarding requirements allows the State to immediately get to work while providing a ramp-up time for providers requiring enrollment for Phase 3. In the event of an unplanned need for an alternate-site vaccination deployment, the flat file roster reporting capability of WebIZ provides an additional emergency capacity.

Data Collection Missouri's ShowMeVax system collects specified demographic information during documentation capture. As required data fields are outlined by CDC guidance for immunization reporting, the

Bureau of Immunization will continue monitoring to ensure the correct information is being captured within SMV and reported as required.

High Volume/Contingency Documentation The WebIZ software has a vaccination module that allows for a mass vaccine import. The Bureau of Immunization will use this tool, as required, although the preferred process is for vaccination administration to enter ShowMeVax in real-time. The Bureau recognizes the potential for network outages, cloud service failures, and their significant impact on documentation efforts. However, all server types (database, web, domain controllers) in our production Azure environments are configured in pairs to provide load balancing in the event of high-traffic events and redundancy in the event of Azure hardware and networking failures. Additionally, customer databases are frequently and regularly backed up to Azure storage using SQL Server-managed backup to Microsoft Azure. In the unlikely event that the Azure data centers experience a catastrophic outage, this would render the site unavailable. Contingency planning for this scenario aligns with that for general web unavailability at a mobile site. Providers use localized tracking (either electronic or manual) through WebIZ's roster import function as soon as connectivity is restored.

Section 12: COVID-19 Vaccination Program Communication

Comprehensive, Coordinated Campaign DHSS submitted a formal request submitted to a state-approved marketing vendor to develop a multi-sourced media campaign encouraging Missourians to get the COVID-19 vaccination, explicitly focusing on stigma reduction and consistent messaging. Campaign media breakout can be found in the appendices.

This campaign will have four primary messaging objectives:

1) Protecting communities 2) Empowering families 3) Stopping myths by highlighting vaccine safety and privacy protection 4) Vaccinating so we can move beyond COVID-19

The campaign end state is Missourians are informed, understand what priority group they are in, and the associated timelines of when the vaccine is available to them. Providers and health departments are adequately trained and equipped to administer vaccines as soon as they are available.

Key Tasks:

1. Provide providers and health departments with education and training materials to safely and timely administer the COVID-19 vaccines and counter myths about the vaccine. a. Included are instructions for the safe handling, storage, preparation, and administration

of the vaccines along with educational material/talking points providers can use to educate Missourians.

2. Inform Missourians on the timeline of vaccine availability, who the targeted populations are, and why the vaccine is essential. a. This is based on the concepts of protecting communities and empowering families. A

multi-sourced media campaign will guarantee timely, accessible, and effective public health and safety messaging for Missouri communities.

The campaign will run from 10 days before vaccine delivery and continue six to eight months after the first vaccine delivery. The vaccine will be available and distributed based on a three-phase approach; however, Phase I and II will be the priority for education and messaging:

Phase One – Phase One intends to reduce morbidity and mortality and provide relief to critically stressed community healthcare resources while protecting those residents engaged in supporting critical infrastructure and economic reopening. This phase is expected to begin upon the vaccine delivery date through approximately 90 days. Vaccines are anticipated to be in limited amounts, with high-risk populations being the primary focus.

• Priority Populations o Phase 1A: All healthcare personnel and staff who have the potential for direct or

indirect exposure to COVID-19 and are unable to work from home

o Phase 1B: Those at increased risk for severe COVID-19 illness, including those ≥ 65 years of age, and those workers who are vital to keeping the essential functions of society running.

Phase Two –Phase Two's intent is to promote the vaccine's safety and the importance of being vaccinated so Missouri can continue to reopen safely. Transition in messaging is anticipated on or about vaccine delivery date plus approximately 90 to 180 days. Phone One messaging will continue through this time.

• Priority populations o Individuals who fall with